510(k) · Cleared
ClearedOtogram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tympany, Inc. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on Sep 3, 2004 as substantially equivalent to K910247 (Madsen Electronics (Canada), Ltd., 1991) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 3, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910247 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910247 Zodiac 901 Middle-Ear AnalyzerMadsen Electronics (Canada), Ltd. · 1991
- This deviceK041853 OtogramTympany, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910247 | Zodiac 901 Middle-Ear Analyzer | Madsen Electronics (Canada), Ltd. | 1991 | — |
| 0 (this device) | K041853 | Otogram | Tympany, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ETW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910247 | Zodiac 901 Middle-Ear AnalyzerSummary page 1…meter, Impedance Audiometer, Otoacoustic Emissions Device 2. Equivalent legally marketed devices This product is similar in design and function to the Madsen Zodiac, K910247 and the Biologic Audx, K974076 3. Indications for Use (intended use) 'Otogram" can perform the functions of: 1. Pure tone and… | 1991 |
| * | K974076 | Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeSummary page 1…oacoustic Emissions Device 2. Equivalent legally marketed devices This product is similar in design and function to the Madsen Zodiac, K910247 and the Biologic Audx, K974076 3. Indications for Use (intended use) 'Otogram" can perform the functions of: 1. Pure tone and speech audiometer, 2. Imped… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K910247.
How does its category compare?
All ETW devicesETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETW
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ETW
Too few ETW 510(k)s in any year since 2007 to give a median.
Recalls per year · ETW
No recall names ETW since 2007.
Adverse event reports per year · ETW
1in 2025
MAUDE reports naming product code ETW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
"Otogram" can perform the functions of:
1. Pure tone and speech audiometer,
2. Impedance audiometer (tympanometry, acoustic reflex), and
3. Distortion product otoacoustic emissions analyzer.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041853: Otogram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041853
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026